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Genzyme Fabrazyme approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA approves Genzyme's Fabrazyme (agalsidase beta) April 24 as the first treatment for Fabry disease. Orphan drug exclusivity will presumably prevent approval of Transkaryotic Therapies' Replagal (agalsidase alfa) through 2010. Approximately 5,000 people worldwide have the disorder, with "over 700 patients" currently diagnosed in the U.S. Genzyme hopes to build the market by targeting the 0.2% of dialysis patients that could have the rare disease and through increased genetic screening. The firm also plans to shift towards treatment initiation at the time of diagnosi

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